Patients' ability to sue at risk

The U.S. Supreme Court, in an 8-1 decision, ruled last month that patients injured by most medical devices can't sue their manufacturers. And this fall, a similar case could extend the same legal protection to the much larger pharmaceutical industry -- a frequent target of lawsuits.

In last month's case, the high court backed a legal theory, supported by the Bush administration, that maintains that the Food and Drug Administration adequately regulates the drug and device industries and should not be second-guessed by courts.

Critics say such an argument would make more practical sense if the FDA were doing a better job.

The high-profile cases come as the federal agency faces growing challenges and some of its most withering criticism in years, some from within its own walls.

In recent weeks, the agency has acknowledged that it never inspected a Chinese factory that produced batches of the blood thinner heparin, which has been linked to as many as 21 deaths. Congress is investigating the agency's handling of cholesterol drug Vytorin in the wake of a study that raised questions about whether the widely advertised blockbuster works any better than a cheaper generic.

The FDA "doesn't have the ability at this time to oversee in a comprehensive fashion everything it regulates," said David A. Kessler, a former FDA chief and a professor at UC San Francisco.

A trio of recent reports, including one by the FDA's own advisory committee, has raised serious questions about the agency's recent performance.

Last fall a yearlong study by the FDA's advisory committee found "the agency is so underfunded and understaffed that it's putting U.S. consumers at risk in terms of food and drug safety."

In an unusual public departure from the view of the Bush administration, the current FDA commissioner, Andrew C. von Eschenbach, said in an interview last week that the agency needed a systemic overhaul that could take years.

In last month's Supreme Court case, the widow of a New York man who died after a balloon catheter burst in his chest during surgery sued the manufacturer, Medtronic Inc., saying the catheter was defective.

Because federal law makes few provisions for suits against drug and device makers, injured patients have turned to state law and won substantial awards.